MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 AST-ST01 TEST KIT; VITEK® 2 AST-ST01 CARD

Catalog Number	410028
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) notified biomérieux of false resistant ceftriaxone results when performing susceptibility testing with vitek® 2 ast-st01 test kit (ref 410028).Vitek® 2 obtained a result of ceftriaxone resistant for streptococcus constellatus.Etest® was performed to confirm the result, and it provided a result of susceptible (mic 0.19).There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.The customer stated there was a delay in reporting patient results of greater than 24 hours.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
A customer in (b)(6) notified biomérieux of false resistant ceftriaxone (cro) results when performing susceptibility testing with vitek® 2 ast-st01 test kit (ref 410028).Vitek® 2 obtained a result of resistant for streptococcus constellatus.Identification of the submitted organism was confirmed, and testing included two cards from the customer lots (5400453103 called cl1 and 5400472203 called cl2) of ast-st01 card, as well as one card from a random lot (5400407213 rl).The reference method used for the development of the incriminated drug was performed in parallel of vt2 testing : broth microdilution (bmd) which is the method used for ceftriaxone development (formulation cr01n) on ast-st01 : cro mic = 0.25 mg/l s (interpretation according to eucast 2017 : s /= 1).On vitek 2 v7.01 (aes parameters : eucast + phenotypic) : the cro value (1 mg/l r) was obtained with the three lots, and is an essential agreement error (+ 2 doubling dilutions) compared to reference mic (bmd = 0.25 mg/l s) which lead to a major error of category.The resistant customer result was reproduced on the three lots tested.An additional biomérieux investigation was conducted into the reported shift to higher ceftriaxone (cro) mics for ast-st01 and ast-st03 cards.The investigation included testing of the development strains to determine if performance of streptococcus anginosus/constellatus has shifted compared to development performance.Forty (40) strains from the ss01 (cro) development set were tested on three lots of ast-st01 cards (lot # 5400407203 - random lot; 5400453103, and 5400472203 - complaint lots); the same cro formulation is used on the ast-st03 cards.Data were integrated and identified there is a shift high in cro mics when compared to development.Many strains demonstrated an mic of 1, which is resistant by eucast breakpoints.For clsi/fda, an mic of 1 is still susceptible, so this shift does not have the same impact when clsi bps are applied.Growth curves show that when a new kit of st1 base broth was qualified, the growth of the anginosus group strains was improved (i.E., the positive growth control well grows faster).This improvement in growth leads to an increase in growth in the cro wells, too, and thus causes an increase in the cro mics.The st1 base broth transition included all claimed streptococcus species.Streptococci other than anginosus group demonstrated adequate performance.Essential agreement (ea) for beta streptococci = 100%, streptococcus pneumonia = 97.5%.The validation summary stated that cro passed overall ea and shift criteria.The transition to a new kit of st1 base broth chemicals led to an increase in growth for the streptococcus anginosus group.This appears to have caused an increase in the mics of cro for this organism group.Other streptococci are not affected.Field safety corrective action (fsca-4075) addresses this issue in the field.The associated urgent product correction notice informs customers of the cro behavior and describes a vitek® 2 eucast limitation to be applied via a vitek® 2 bioart rule.The bioart rule will instruct the user to perform an alternate method of testing prior to reporting resistant results for the identified organism/antibiotic combination.

• Brand Name: VITEK® 2 AST-ST01 TEST KIT
• Common Device Name: VITEK® 2 AST-ST01 CARD
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• MDR Report Key: 7122254
• Report Number: 1950204-2017-00460
• Device Sequence Number: 1210259
• Product Code: LON
• UDI-Device Identifier: 03573026345334
• UDI-Public: 03573026345334
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: N50510: S135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/13/2019
• Device Catalogue Number: 410028
• Device Lot Number: 5400472203
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2017
• Supplement Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 12/15/2017
• Supplement Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1